MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY COLD KNIFE

Model Number 27033W-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

Scope 27033aa is the model number listed on the original medwatch ((b)(4)) filed by the hospital.During follow up with the doctor, we learned that a sickle cold knife was being used when injury occurred which we believe was a 27033w-s.There was no report of malfunction.The hospital did not return the device.Hospital could not find.

Event Description

Allegedly, the patient was scheduled for a cystoscopy with transurethral incision of posterior urethral valves and circumcision.During cystoscopy, patent became hemodynamically unstable and procedure was stopped.The patient was stabilized and transferred to pediatric intensive care unit (picu) where he continued to decompensate.After approximately 3 hours, he returned to the operating room for a stat exploratory laparotomy and it was discovered that the left iliac vein and artery was lacerated.The vessels were immediately clamped to control bleeding.The vascular team was contacted and the artery was repaired without difficulty.The patient improved immediately and was readmitted to the picu for four days.He was later transferred to an inpatient room and discharged eleven days after admission.

• Brand Name: COLD KNIFE
• Type of Device: COLD KNIFE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188519
• MDR Report Key: 6494698
• MDR Text Key: 72877014
• Report Number: 9610617-2017-00029
• Device Sequence Number: 1
• Product Code: EZO
• UDI-Device Identifier: 04048551393062
• UDI-Public: 4048551393062
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 27033W-S
• Device Catalogue Number: 27033W-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 1 MO
• Patient Weight: 4